Dandruff, seborrheic dermatitis and scalp psoriasis are symptomatic diseases resulting from a progessively increasing turnover rate of the epidermal cells of the scalp basale lamina and sebaceous glands. Sebum is known to be toxic to the epidermis onto which it flows. It is presently postulated that excessive sebum production from the pathological condition of multiple layers of growth cells in the periphery of the sebaceous gland increases this toxicity, resulting in premature necrosis and replacement of the scalp epidermis. Excessive sebum production will manifest itself as mounds or scales of exudate on the epidermis and as follicular plugs. Heretofore, these conditions could only be "treated" or "relieved" and prior compositions for treating and relieving these disease have been found to be without significant or permanent success.
The use of magnesium aluminum silicates and other alumina silicates in certain medical and health products as an inert ingredient is well-known. In 1982, the FDA attempted, via the Federal Register, to establish a monograph for non-prescription or over-the-counter (OTC) drug products for the control of dandruff, seborrheic dermatitis and psoriasis. It reviewed 85 ingredients contained in marketed products, 32 other ingredients classified as active, and 24 inactive ingredients. None of these reviewed ingredients were magnesium aluminum silicate. In an independent survey of all available OTC drug products for treatment of scalp diseases, comprising a total of 49 ingredients, only two listed magnesium aluminum silicate as ingredients. However, in the first case, sulfur, a keratolytic, was listed as the active ingredient and, in the second case, zinc pyrithione, a cytostatic, was the listed active ingredient.
The cation exchange capacity (CEC) of certain mineral clays is also generally well-documented and this property is utilized in many industrial and soil chemistry applications. However, there is no evidence in the literature of using the CEC of certain clays to release magnesium cations for physiological results. Further, there is no evidence in the literature to suggest that the delivery of such cations to the cytoplasm of covering epithelia would return certain pathological cells to normal, resulting in a normal mitotic rate. There is also no evidence in the literature to suggest that magnesium aluminum silicate may be used in any medicament other than as an inert ingredient, notwithstanding its swellability.
It is, accordingly, a primary object of the invention to provide a composition for the effective treatment of dandruff, seborrheic dermatitis and scalp psoriasis.
It is also a primary object of the invention to provide a composition which utilizes the cation exchange capacity of certain clay minerals to release and deliver magnesium cations (Mg.sup.++) and hydroxyl anions (OH.sup.31 ) to diseased dermal growth cells and diseased sebaceous gland cells to effectively treat epidermal and sebaceous disorder.
It is a further object of the invention to provide an effective method for returning pathological cells, characteristic of scalp diseases of the dermal basale lamina and peripheral cells of the sebaceous glands, to a normal conformation and a normal mitotic rate.
Another object of the present invention is to provide an orderly description of the varied and complex disciplines that contribute to and participate in the multifactorial mechanisms of the compositions provided by the invention.